Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-28 @ 7:25 PM
Study NCT ID:
NCT01357356
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2011-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053158', 'term': 'Nocturia'}], 'ancestors': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sfein@serenitypharma.com', 'phone': '8456396760', 'title': 'Chief Medical Officer', 'phoneExt': '17', 'organization': 'Serenity Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse events were collected from the Safety Population, i.e., any patient who had received one dose of study drug and reported an adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'SER120 750 ng', 'description': 'all participants received SER120 750 ng once daily', 'otherNumAtRisk': 188, 'otherNumAffected': 18, 'seriousNumAtRisk': 188, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'SER120 1000 ng', 'description': 'all participants received SER120 1000 ng once daily', 'otherNumAtRisk': 186, 'otherNumAffected': 15, 'seriousNumAtRisk': 186, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'SER120 1500 ng', 'description': 'all participants received SER120 1500 ng once daily', 'otherNumAtRisk': 184, 'otherNumAffected': 21, 'seriousNumAtRisk': 184, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Placebo', 'description': 'all participants received Placebo once daily', 'otherNumAtRisk': 187, 'otherNumAffected': 19, 'seriousNumAtRisk': 187, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tongue neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous cell carcinoma skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in # of Mean Nocturic Episodes Per Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SER120 750 ng', 'description': 'all participants received SER120 750 ng once daily'}, {'id': 'OG001', 'title': 'SER120 1000 ng', 'description': 'all participants received SER120 1000 ng once daily'}, {'id': 'OG002', 'title': 'SER120 1500 ng', 'description': 'all participants received SER120 1500 ng once daily'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'all participants received placebo once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '0.07', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12', 'unitOfMeasure': 'nocturic episodes per night', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}, {'type': 'PRIMARY', 'title': 'Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '186', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SER120 750 ng', 'description': 'All participants received SER120 750 ng once daily'}, {'id': 'OG001', 'title': 'SER120 1000 ng', 'description': 'all participants received SER120 1000 ng once daily'}, {'id': 'OG002', 'title': 'SER120 1500 ng', 'description': 'all participants received SER120 1500 ng once daily'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'all participants received Placebo once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SER120 750 ng', 'description': 'All participants received SER120 750 ng once daily'}, {'id': 'FG001', 'title': 'SER120 1000 ng', 'description': 'All participants received SER120 1000 ng once daily'}, {'id': 'FG002', 'title': 'SER120 1500 ng', 'description': 'All participants received SER120 1500 ng once daily'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'All participants received Placebo once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '188'}, {'groupId': 'FG002', 'numSubjects': '186'}, {'groupId': 'FG003', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '163'}, {'groupId': 'FG002', 'numSubjects': '158'}, {'groupId': 'FG003', 'numSubjects': '171'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}, {'value': '734', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'SER120 750 ng', 'description': 'All participants received SER120 750 ng once daily'}, {'id': 'BG001', 'title': 'SER120 1000 ng', 'description': 'All participants received SER120 1000 ng once daily'}, {'id': 'BG002', 'title': 'SER120 1500 ng', 'description': 'All participants received SER120 1500 ng once daily'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'All participants received Placebo once daily'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '66.1', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '66.0', 'spread': '9.4', 'groupId': 'BG002'}, {'value': '66.0', 'spread': '10.1', 'groupId': 'BG003'}, {'value': '66.1', 'spread': '9.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '302', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}, {'value': '432', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}, {'value': '635', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}, {'value': '677', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-to-treat population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'dispFirstSubmitDate': '2015-11-23', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2011-05-18', 'dispFirstSubmitQcDate': '2015-11-23', 'resultsFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2011-05-19', 'dispFirstPostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-14', 'studyFirstPostDateStruct': {'date': '2011-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in # of Mean Nocturic Episodes Per Night', 'timeFrame': '12 weeks', 'description': 'Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12'}, {'measure': 'Percent of Participants With 50% or Greater in Reduction of Nocturic Episodes', 'timeFrame': '12 weeks', 'description': 'Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nocturia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female 50 years or older\n* Nocturia of 6 or more months duration averaging greater than 2 nocturic episode per night\n\nExclusion Criteria:\n\n* CHF\n* Diabetis Insipidus\n* Renal Insufficiency\n* Hepatic Insufficiency\n* Incontinence\n* Illness requiring systemic steroids\n* Malignancy within the past 5 years\n* Sleep Apnea\n* Nephrotic Syndrome\n* Unexplained Pelvic Mass\n* Urinary Bladder Neurological dysfunction\n* Urinary Bladder Surgery or Radiotherapy\n* Pregnant or Breast Feeding'}, 'identificationModule': {'nctId': 'NCT01357356', 'briefTitle': 'Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Serenity Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients With Nocturia', 'orgStudyIdInfo': {'id': 'SPC-SER120-DB3-201101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SER120 (750 ng/day)', 'description': 'SER120 (750 ng/day)', 'interventionNames': ['Drug: SER120 (750 ng/day)']}, {'type': 'EXPERIMENTAL', 'label': 'SER120 (1000 ng/day)', 'description': 'SER120 (1000 ng/day)', 'interventionNames': ['Drug: SER120 (1000 ng/day)']}, {'type': 'EXPERIMENTAL', 'label': 'SER120 (1500 ng/day)', 'description': 'SER120 (1500 ng/day)', 'interventionNames': ['Drug: SER120 (1500 ng/day)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SER120 (750 ng/day)', 'type': 'DRUG', 'armGroupLabels': ['SER120 (750 ng/day)']}, {'name': 'SER120 (1000 ng/day)', 'type': 'DRUG', 'description': 'SER120 (1000 ng/day)', 'armGroupLabels': ['SER120 (1000 ng/day)']}, {'name': 'SER120 (1500 ng/day)', 'type': 'DRUG', 'armGroupLabels': ['SER120 (1500 ng/day)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10956', 'city': 'New City', 'state': 'New York', 'country': 'United States', 'facility': 'Serenity R&D', 'geoPoint': {'lat': 41.1476, 'lon': -73.98931}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Serenity Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}